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Paola Maria Cutroneo, Daniele Sartori, Marco Tuccori, Salvatore Crisafulli, Vera Battini, Carla Carnovale, Concetta Rafaniello, Annalisa Capuano, Elisabetta Poluzzi, Ugo Moretti, Emanuel Raschi
as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient, their role remain irreplaceable for rapid detection of rare and unpredictable adverse drug reactions with strong drug-attributable component (e.g., designated medical events), especially when developed by a multidisciplinary team and combined with a careful case-by-case analysis (individual inspection of reports for causality assessment or to uncover reporting patterns and clinical features). In the recent past, a remarkable increase in publications of pharmacovigilance studies using DAs was observed, albeit the quality was debated: several publications contained "spin", namely, misinterpretation of results to infer causality, calculate incidence, or provide risk stratification, which may ultimately result in unjustified alarm. The development of dedicated Guidelines by the international READUS-PV project (https://readus-statement.org/) will allow reproducible and transparent publication of accurate DAs, thus supporting their real transferability and exploitation by regulators and clinicians. This review offered a perspective on methodological aspects (and understanding) of DAs, their rationale, design, reporting, and interpretation.
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Cutroneo, P. M., Sartori, D., Tuccori, M., Crisafulli, S., Battini, V., Carnovale, C., Rafaniello, C., Capuano, A., Poluzzi, E., Moretti, U., & Raschi, E. (2024). Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems. Frontiers in Drug Safety and Regulation, 3, 1323057. https://doi.org/10.3389/fdsfr.2023.1323057
Cutroneo, Paola Maria, et al. "Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems." Frontiers in Drug Safety and Regulation, vol. 3, 2024, pp. 1323057, https://doi.org/10.3389/fdsfr.2023.1323057.
Cutroneo, Paola Maria, Daniele Sartori, Marco Tuccori, Salvatore Crisafulli, Vera Battini, Carla Carnovale, Concetta Rafaniello, et al. "Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems." Frontiers in Drug Safety and Regulation 3 (2024): 1323057. https://doi.org/10.3389/fdsfr.2023.1323057.
Cutroneo P. M., Sartori D., Tuccori M. [и др.] Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems // Frontiers in Drug Safety and Regulation. — 2024. — Vol. 3. — P. 1323057. — URL: https://doi.org/10.3389/fdsfr.2023.1323057
@article{cutroneo2024conducting,
title = {{Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems}},
author = {Paola Maria Cutroneo and Daniele Sartori and Marco Tuccori and Salvatore Crisafulli and Vera Battini and Carla Carnovale and Concetta Rafaniello and Annalisa Capuano and Elisabetta Poluzzi and Ugo Moretti and Emanuel Raschi},
journal = {Frontiers in Drug Safety and Regulation},
year = {2024},
volume = {3},
pages = {1323057},
doi = {10.3389/fdsfr.2023.1323057},
url = {https://doi.org/10.3389/fdsfr.2023.1323057}
}TY - JOUR AU - Cutroneo, Paola Maria AU - Sartori, Daniele AU - Tuccori, Marco AU - Crisafulli, Salvatore AU - Battini, Vera AU - Carnovale, Carla AU - Rafaniello, Concetta AU - Capuano, Annalisa AU - Poluzzi, Elisabetta AU - Moretti, Ugo AU - Raschi, Emanuel TI - Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems JO - Frontiers in Drug Safety and Regulation VL - 3 SP - 1323057 PY - 2024 DA - 2024/01/25 DO - 10.3389/fdsfr.2023.1323057 UR - https://doi.org/10.3389/fdsfr.2023.1323057 ER -
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